Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-LFOL522

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091699,K091699,K091699

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

b30a1551-a8c2-4874-83ff-66c8853f381f

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

January 03, 2020

Package DI Number

40612479247428

Quantity per Package

20

Contains DI Package

20612479247417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case